If you’ve ever skipped over`the results section of a medical paper because terms like “confidence interval” or “p-value” go over your head, then you’re in the right place. You may be a clinical practitioner reading research articles to keep up-to-date with developments in your field or a medical student wondering how to approach your own research. Greater confidence in understanding statistical analysis and the results can benefit both working professionals and those undertaking research themselves.
If you are simply interested in properly understanding the published literature or if you are embarking on conducting your own research, this course is your first step. It offers an easy entry into interpreting common statistical concepts without getting into nitty-gritty mathematical formulae. To be able to interpret and understand these concepts is the best way to start your journey into the world of clinical literature. That’s where this course comes in - so let’s get started!
The course is free to enroll and take. You will be offered the option of purchasing a certificate of completion which you become eligible for, if you successfully complete the course requirements. This can be an excellent way of staying motivated! Financial Aid is also available.

AA

A great introduction to understanding research and a great platform to springboard keen clinicians into performing their own research. Will take what I've learnt and apply it to my own research!

DS

May 27, 2018

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I'm very new at this theme, this course has being the perfect beginning. If you don't have a mathematical background and you don't understand when the funny S appear, this is the course for you!

From the lesson

Getting things started by defining study types

Welcome to the first week of this course. We’ll be tackling five broad topics to provide you with an intuitive understanding of clinical research results. This isn’t a comprehensive statistics course, but it offers a practical orientation to the field of medical research and commonly used statistical analysis. The first topics will look at research methods and the collection of data - with a specific focus on study types. By the end of the lectures you should be able to identify which study types are being used and why the researchers selected them when you are reading a paper.

Taught By

Juan H Klopper

Dr

Transcript

Now we're really going to ramp things up. We get to experimental studies. We're actually going to intervene. Now I want to start off with an example straight off the bat. Moorthy and colleagues, they looked at randomizing the administration of anti-malarial vaccines. So they did an experimental group who actually received two anti-malarial vaccines and then they had a control group who did not receive the vaccine. In actual fact, they received rabies vaccine. That was very interesting trial. They really thought they didn't want people volunteered for this study to go home, so to say empty handed. They wanted them to benefit from the study as well. And that the rabies vaccine does not prevent malaria in any way so that still formed the property control group. But at least the patients benefited from being involved with this trial. Now because humans were involved in this, we call it a clinical trial. So if humans are involved, we call an experimental study a clinical trial. So what happened here? There was an active intervention. Now we can decide to omit an intervention that could also constitute But most commonly we are going to actively intervene in some way and in another group, our control groups we won't and we can compare those two. Now this action, this intervention we do that really defines our experimental group. Now we needn't just have one experimental group as in this example, I might have a variety of drugs that I want to test and I can form different groups and each of those would get that intervention. Very importantly though is this control group. Now there's different ways to set them up. Now in this instance, they got a totally different vaccine, which didn't interfere with the study at all. We can give patients a sham intervention, we've all heard of that, they get a placebo drug, or even placebo or sham surgery, I should say. Or you can just form a group on controls who just get the normal routine form of therapy. So there are many ways to set up your control group. The whole aim about a clinical trial, about an experimental study is to reduce bias. I mentioned bias many times in the negative column when we looked at observation studies and we really want to reduce that to a minimum and that's why we design experimental studies. Very important in experimental studies is this randomization process. So what does that entail? Well, in the ideal world we'll have a list of the whole population in the study and we want to draw from that whole list, at random, some individuals. So much so that each individual has exactly the same likelihood of being chosen. So we really have an importance here of having the whole list, the whole list of the population, and obviously that's almost never the case. So there's always some bias involved here just to start off with. But what we want in the end is just assurance that there is some equal spread of possible patients that could enter a trial. So if we look at this example of ours of the antimalarial vaccine, they chose volunteers from areas and villages near a river. So you can already ask yourself how unbiased was this choice, this randomization? What about people who lived further away? Well, they offer the way from the mosquitos, but you've got to consider all these things when you read a trial and you read about their randomization process. Now the next important topic I want to talk about is the blinding. And that is forms a very important part of a clinical trial. Now we can blind subject to the treatment and that's actually at the norm and really in most cases should be done. So volunteers or the participants in a clinical trial should not know if they receive sham treatment, if they're part of the control group, or the actual experimental drug or procedure. Only after the study should this be revealed. Now we can also blind the caregivers so that they don't know whether they're giving a sham treatment, whether this person is part of the control group or actually doing the intervention. Now that's easily enough for the drug. We can make two tablets look exactly the same but more difficult when it comes to surgery. You can't really blind the surgeon as to the procedure that he or she is performing. But we can at least blind observer, the person who takes the data after the intervention. If both the observer and the patient is blind, we call it a double-blinded study. And if it's, well, randomized, it'll be a randomized Study. Now let's talk just a little bit more about these controlled groups. As I said. They can just be a sham control so they need to have a sham procedure or take a placebo drug. But we can have other forms of controls as well. For instance the self-controls. Now what we would do under those circumstances, is we would take some data on a patient, we would then intervene and take that same data after the intervention. So the same tests that we're going perform both before and after so that patient is in his or her own control. We can make that even more interesting by doing a crossover trial. So we can have two sets of patients, one with the placebo drug, one not with the actual drug. They're each going to be their own controls, so we'll do some studies before and after that intervention. A period of time will go by and we'll actually swap them around, so those who got the, received, the placebo drug will now receive the actual drug and vice versa and then we'll compare them. So that's very interesting crossover trial, where the patients initially at least are their own controls. We'll can also look at external controls for instance historical controls. Be important if no treatment in an certain area existed before we did this trial. We can also do totally uncontrolled trials where we're just looking at variations and outcomes and you'll form the groups based on those. In many ways to setup the controls. What we're really after, what is the gold standard in clinical research today is the double-blind randomized control trial. That is really what we're after, it gives us the most power, the most information, and the most trustworthy information in the questions that we have in medical research and in the medical literature. Next up, we're going touch on two very important topics that have meta-analysis and the systematic review.

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